Pharmacokinetics of Dipyridamole Administered as Aggrenox® (Dipyridamole Extended Release Plus Aspirin) Capsule Versus Dipyridamole Immediate Release Plus Aspirin Following Alteration of Stomach pH

Overview

Comparison of pharmacokinetics of dipyridamole administered as Aggrenox versus dipyridamole administered as the immediate release formulation plus aspirin, under conditions of reduced stomach acidity.

Full Title of Study: “Comparison of Pharmacokinetics of Dipyridamole Administered as Aggrenox® (Dipyridamole Extended Release Plus Aspirin) Capsule Versus Dipyridamole Immediate Release Plus Aspirin Following Alteration of Stomach pH by the Prior Administration of a Proton-pump Inhibitor: An Open-label 2-way Randomized Cross-over Study in Healthy Male and Female Subjects Age 40-65.”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Crossover Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: November 2000

Interventions

  • Drug: Aggrenox
  • Drug: Dipyridamole
  • Drug: Aspirin
  • Drug: Lansoprazole

Arms, Groups and Cohorts

  • Experimental: Aggrenox
    • extended release
  • Active Comparator: dipyridamole+aspirin
    • immediate release

Clinical Trial Outcome Measures

Primary Measures

  • area under the concentration time curve (AUC0-12)
    • Time Frame: up to 12 hours

Secondary Measures

  • area under the concentration time curve 0-48 hours (AUC0-48)
    • Time Frame: up to 48 hours
  • area under the concentration time curve extrapolated to infinity (AUC0-inf)
    • Time Frame: up to 3 days
  • maximum observed plasma concentration (Cmax)
    • Time Frame: up to 3 days
  • time to maximum observed plasma concentration (Tmax)
    • Time Frame: up to 3 days
  • terminal half life (t1/2)
    • Time Frame: up to 3 days
  • number of subjects with adverse events
    • Time Frame: up to 3 weeks
  • number of subjects with clinically significant changes in laboratory findings
    • Time Frame: up to 17 days

Participating in This Clinical Trial

Inclusion Criteria

  • Healthy subjects as determined by results of screening – Signed written informed consent in accordance with Good Clinical Practice (GCP) and local legislation – Age 40 – 65 years, inclusive, at time of Visit 1 – Stomach pH > 4.0 on three consecutive measurements separated by at least five minutes, measured at Visits 3B and 5B prior to dosing with Aggrenox or dipyridamole-aspirin (DP-ASA) Exclusion Criteria:

  • Any findings of the medical examination (including blood pressure, pulse rate and ECG) deviating from normal and considered by the investigator to be of clinical relevance – Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders considered by the investigator to be of clinical relevance – History of gastro-intestinal ulcer, perforation or bleeding – Surgery of the gastro-intestinal tract (except appendectomy) – Diseases of the central nervous system (such as epilepsy), neurological disorders, or psychiatric disorders – Chronic or relevant acute infections. Screening tests will be performed for HIV, hepatitis B, and hepatitis C – History of hypersensitivity to Aggrenox or any of the components or excipients – Intake of drugs with a long dominant half-life (>24 hours) 1 month or less prior to Visit 1 – Use of any drugs which might influence the results of the trial ten days or less prior to Visit 1 – Participation in another trial with an investigational drug 1 month or less prior to Visit 1 – Known alcohol abuse – Known drug abuse (a drug screening test will be performed at Visits 1, 3, and 5) – Blood donation 1 month or less prior to Visit 1 – Excessive physical activities five days or less prior to Visit 1 – History of hemorrhagic diathesis – History of bronchial asthma – Any laboratory value outside the reference range, considered by the investigator to be of clinical relevance For female subjects: – Nursing – Pregnancy – Positive pregnancy test – No adequate contraception (adequate contraception includes sterilization, intrauterine device, or oral contraceptives) – Inability to maintain adequate contraception during the whole study period

Gender Eligibility: All

Minimum Age: 40 Years

Maximum Age: 65 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Boehringer Ingelheim
  • Provider of Information About this Clinical Study
    • Sponsor

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